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临床试验/NCT04320472
NCT04320472Unknown不适用

Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection

Ictal Group39 个研究点 分布在 7 个国家目标入组 250 人开始时间: 2020年3月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
Ictal Group
入组人数
250
试验地点
39
主要终点
prevalence

研究概览

简要总结

Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare.

The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients.

Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity.

Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients.

We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

详细描述

All patients with SARS-CoV-2 infection and acute encephalopathy at presentation will be prospectively included in the NEURO-COVD-19 study. This study will collect demographic data, clinical examen at prehospital/emergency room and ICU admission (including neurological signs), and all ancillary exams performed to identify a cause of neurological impairment. Outcome will be evaluated using the Glasgow Outcome Scale score at ICU and hospital discharge, and day-90 after ICU admission.

Acute encephalopathy will be defined as recently stated :

"1. The term acute encephalopathy refers to a rapidly developing (over less than 4 weeks, but usually within hours to a few days) pathobiological process in the brain. This is a preferred term 2. Acute encephalopathy can lead to a clinical presentation of subsyndromal delirium, delirium, or in case of a severely decreased level of consciousness, coma; all representing a change from baseline cognitive status 3. The term delirium refers to a clinical state characterized by a combination of features defined by diagnostic systems such as the DSM-5. Delirium according to the DSM-5 is defined if criterium A-E are fulfilled: A. Disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment). B. The disturbance develops over a short period of time (usually hours to a few days) represents a change from baseline attention and awareness, and tends to fluctuate in severity during the course of the day. C. An additional disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception). D. The disturbances in criteria A and C are not explained by another pre-existing, established, or evolving neurocognitive disorder, and do not occur in the context of a severely reduced level of arousal, such as coma. E. There is evidence from the history, physical examination, or laboratory findings that the disturbance is a direct physiologic consequence of another medical condition, substance intoxication or withdrawal (i.e. because of a drug of abuse medication), or exposure to a toxin, or is because of multiple etiologies. " (Slooter, A.J.C., Otte, W.M., Devlin, J.W. et al. Updated nomenclature of delirium and acute encephalopathy: statement of ten Societies. Intensive Care Med (2020). https://doi.org/10.1007/s00134-019-05907-4)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critical/Intensive care or Neurocritical care admission
  • Admission for/with acute encephalopathy defined as a rapidly developing (over less than 4 weeks, but usually within hours to a few days) pathobiological process in the brain; including delirium or subsyndromal (DSM V definition) or coma (Glasgow coma scale score < 9)
  • SARS-COV-2 infection (respiratory or other PCR specimen)
  • Age ≥ 18 years

排除标准

  • Opposition to study participation from the patient itself or patient surrogate

结局指标

主要结局

prevalence

时间窗: at Critical/Intensive care or Neurocritical care admission

ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at Critical/Intensive care or Neurocritical care admission

次要结局

  • Favorable outcome(3 months)

研究者

发起方
Ictal Group
申办方类型
Other
责任方
Sponsor

研究点 (39)

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